NCT00226044

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 6 Weeks – 3 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

Detailed description

Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day. Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.

Conditions

• Gastroesophageal Reflux
• Esophageal Atresia
• Hernia, Diaphragmatic

Interventions

Type	Name	Description
DRUG	Omeprazole rectally 1mg/kg	A single dose of 1 mg/kg rectally administered omeprazole.

Timeline

• Start date: 2005-09-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2005-09-26
• Last updated: 2019-10-07

Locations

1 site across 1 country: Netherlands